search
Back to results

Topical Silver for Prevention of Wound Infection After Cesarean Delivery

Primary Purpose

Wound Infection

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Silver-containing surgical dressing
Cloth adhesive dressing
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wound Infection focused on measuring Wound infection prevention, Silver-containing surgical dressing, Cesarean delivery infection prevention

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Cesarean delivery with pfannenstiel incision

Exclusion Criteria:

  • Incision other than pfannenstiel
  • Silver allergy
  • Inability to provide informed consent

Sites / Locations

  • Vanderbilt University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Silver-containing surgical dressing

Cloth adhesive dressing

Arm Description

Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver

Soft cloth adhesive wound dressing

Outcomes

Primary Outcome Measures

Silver Treatment Efficacy
As measured by number of patients with postop infections at 6 wks

Secondary Outcome Measures

Infection Rate Adjusted for Maternal BMI
Patient Dressing Cost
Total cost of dressings per group based on 1 dressing per patient

Full Information

First Posted
July 22, 2010
Last Updated
April 19, 2017
Sponsor
Vanderbilt University
search

1. Study Identification

Unique Protocol Identification Number
NCT01169064
Brief Title
Topical Silver for Prevention of Wound Infection After Cesarean Delivery
Official Title
Topical Silver for Prevention of Wound Infection Post Cesarean Delivery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis showed no statistical significance achieved.
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A common concern in any surgical procedure is the occurrence of infection. Silver-containing treatments are popular and used in wound treatment; however, there is presently little evidence of the effectiveness of silver-containing treatment for the prevention of obstetrical wound infection. We plan to investigate the rate of infection in women experiencing cesarean sections at Vanderbilt University Medical Center (VUMC) by comparing the infection rate based on a randomized choice of silver-containing wound dressings to soft cloth adhesive wound dressings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
Keywords
Wound infection prevention, Silver-containing surgical dressing, Cesarean delivery infection prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
475 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silver-containing surgical dressing
Arm Type
Active Comparator
Arm Description
Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver
Arm Title
Cloth adhesive dressing
Arm Type
Active Comparator
Arm Description
Soft cloth adhesive wound dressing
Intervention Type
Device
Intervention Name(s)
Silver-containing surgical dressing
Other Intervention Name(s)
Acticoat
Intervention Description
Dressing placed over surgical incision and remain for 3-5 days
Intervention Type
Device
Intervention Name(s)
Cloth adhesive dressing
Other Intervention Name(s)
Medipore
Intervention Description
Cloth adhesive dressing placed over surgical incision and remains for 3-5 days
Primary Outcome Measure Information:
Title
Silver Treatment Efficacy
Description
As measured by number of patients with postop infections at 6 wks
Time Frame
6 weeks postpartum
Secondary Outcome Measure Information:
Title
Infection Rate Adjusted for Maternal BMI
Time Frame
6 weeks postpartum
Title
Patient Dressing Cost
Description
Total cost of dressings per group based on 1 dressing per patient
Time Frame
Postoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cesarean delivery with pfannenstiel incision Exclusion Criteria: Incision other than pfannenstiel Silver allergy Inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly A. Bennett, MD
Organizational Affiliation
Vanderbilt University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Topical Silver for Prevention of Wound Infection After Cesarean Delivery

We'll reach out to this number within 24 hrs